HANGZHOU, China & NEWARK, Calif.--(BUSINESS WIRE)--Atom Therapeutics, an innovative biotechnology company focused on the discovery and development of novel therapies for metabolic, inflammatory, and cardiovascular diseases, today announced the initiation of its Phase 3 clinical trial in China for lingdolinurad (ABP-671). The first patient has been successfully enrolled and dosed.
The Phase 3 portion of this multicenter, randomized, double-blind, parallel-controlled Phase 2b/3 clinical trial plans to enroll more than 800 gout patients in China. The study will directly compare lingdolinurad with febuxostat to evaluate its efficacy and safety in patients with gout. Tophaceous gout patients will be included in this study to evaluate lingdolinurad’s potential to reduce the size or eliminate tophi. The results are expected to provide robust and reliable evidence to support future regulatory submissions for marketing approval in China.
Dr. William Dongfang Shi, Founder, Chairman and CEO of Atom Therapeutics, commented, “Lingdolinurad is being developed under a synchronized clinical development strategy in both China and the US. In addition to the ongoing Phase 3 clinical trial in China, the overseas Phase 3 program, which is primarily conducted in the US, has been reviewed by the FDA and is planned to be initiated later this year.”
Dr. Shi added, “Lingdolinurad is one of Atom Therapeutics’ core assets. It has demonstrated favorable efficacy and a well-tolerated safety profile. Notably, lingdolinurad has shown strong evidence of reducing and eliminating tophi in the subset tophaceous gout patients, and significantly lowering the incidence of acute gout flares in the phase 2b studies—key clinical advantages that remain challenging for existing gout therapies to achieve. We look forward to the timely completion of the Phase 3 clinical program, with the goal of providing more effective, safer, and long-term treatment options for over 60 million gout patients and more than 300 million individuals with hyperuricemia worldwide.”
Gout is a chronic disease caused by long-term hyperuricemia (serum uric acid level >7 mg/dL or 420 μmol/L). It may lead to joint deformities and chronic kidney disease. Recurrent gout attacks over time can not only cause severe joint pain but may also increase the risk of sudden death. Current urate-lowering therapies are limited in availability and often associated with suboptimal efficacy and significant safety concerns, failing to meet the needs of a large gout patient population.
Lingdolinurad is being developed for treatment of hyperuricemia and chronic gout, including tophaceous gout and refractory gout. It achieves potent urate-lowering effects by inhibiting renal tubular urate reabsorption and promoting uric acid excretion.
The Phase 2b data from the China Phase 2b/3 clinical trial demonstrated that after 8 weeks of administration of lingdolinurad at a dose of 2 mg twice daily (with baseline serum uric acid levels of 9.8 mg/dL or 588 μmol/L), the proportions of subjects with serum uric acid levels below 6 mg/dL (360 μmol/L, the primary endpoint), 5 mg/dL (300 μmol/L), and 4 mg/dL (240 μmol/L) exceeded 91%, 83%, and 63%, respectively, showing significantly superior efficacy compared to febuxostat, all with statistical significance.
Additionally, lingdolinurad exhibited outstanding tophi dissolution capability, with complete resolution of tophi observed in some subjects within less than 6 months of treatment. A recent clinical trial of lingdolinurad in the US indicated that within 3-6 months post-administration, the incidence of acute gout attacks decreased by 67% compared to placebo group. In terms of safety, adverse events were predominantly mild to moderate, with no severe adverse events reported, fully demonstrating the excellent safety profile and tolerability of lingdolinurad.
ABP-745, another novel anti-inflammatory drug developed by Atom Therapeutics, inhibits the assembly of the NLRP3 inflammasome and strongly suppresses multiple inflammatory cytokines, including IL-1β, IL-6, IL-18, and TNF-α. ABP-745 has demonstrated a significantly better safety profile than colchicine, with no observed risk of drug-drug interactions. Currently, a global multicenter Phase 2 clinical trial of ABP-745 for acute gout flares is ongoing in the US, China, and Australia, and is nearing completion of patient dosing.
A global Phase 2 trial of ABP-745 for ASCVD (atherosclerotic cardiovascular disease) is also progressing steadily, with the first patient dosed in April 2026. In an atherosclerosis mice model, ABP-745 when used in combination with atorvastatin, reduced the plaque area by 75% while atorvastatin alone only reduced the plaque area by 50%. In addition, Atom Therapeutics is also preparing a global Phase 2 study in heart failure and pericarditis with ABP-745.
About Atom Therapeutics
Atom Therapeutics Co., Ltd is a fast-growing innovative clinical stage biotechnology company focused on development of novel therapies for metabolic, inflammatory, and cardiovascular diseases. The company's lead product, lingdolinurad (ABP-671), is currently undergoing Phase 3 clinical trial in China. The US and global phase 3 trials of lingdolinurad are in preparation for initiation in Q4, 2026. It is being developed for treatment of chronic gout, hyperuricemia, tophaceous gout, and refractory gout. Another small molecule ABP-745 for anti-inflammatory and autoimmune conditions is in clinical development stage. Its global multicenter Phase 2 clinical trial for treatment of acute gout flares is nearing completion, while a global multicenter Phase 2 study for ASCVD (atherosclerotic cardiovascular disease) is currently ongoing. In addition, Phase 2 clinical trials of ABP-745 are planned for indications including heart failure and pericarditis. For more information, visit: www.atomthera.com or atomthera.us.
Contacts
Media Contact:
Daniel Eramian
Opus Biotech Communications
http://opusbiotech.com/
425-306-8716
Business Development Contact:
Roy J. Wu, MBA
Sr. Vice President, Business Development
Atom Therapeutics Co., Ltd
Email: roy.wu@atombp.com
